CDRH, ORA Plan Specialized Field Force, And To Build On “Case for Quality”-thegraysheet: FDA’s Office of Regulatory Affairs will establish a more specialized unit of device-focused field investigators under a CDRH-ORA program alignment action plan (PDF)posted Oct. 7. CDRH will work together with ORA throughout the current fiscal year to develop a plan for establishing a “medical device inspectorate,” and a separate mammography quality inspectorate, under the steps announced this week. In addition, the departments will hatch a plan for creating a CDRH-ORA medical device and radiological health compliance group.
